MetaMedical™ Solutions Inc

ResMed issues urgent field safety notice for AirFit masks

ResMed has issued an urgent field safety notice for certain models of its AirFit masks that contain magnets, citing issues around interference with medical implants.

In a letter sent to patients on 20 November, the US-headquartered company updated the contraindications and warnings in the user guides for the masks.

The masks affected include multiple AirFit models from its full-face mask, nasal mask, and non-vented mask ranges and are used to deliver air from a positive airway pressure (PAP) device.

The masks use magnets to provide easier attachment and detachment to headgear. The company says their use is especially important to patients with dexterity vision impairment, or those with disabilities.

The safety notice is due to reports of magnetic interference of the magnets with implanted devices in the patient. ResMed has submitted five reports of serious harm, potentially caused by this issue, to regulatory authorities. No deaths have been reported.

ResMed said that medical device function could be affected, whilst ferromagnetic implants could change position because of mask magnet proximity.

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Active medical implants that could be affected include cardiovascular devices such as pacemakers, and implantable cardioverter defibrillators (ICD). Neurostimulators and cerebrospinal fluid (CSF) shunts can also suffer from interference, along with diabetes devices such as insulin/infusion pumps.

ResMed also stated that patients with metallic implants containing ferromagnetic materials are contraindicated for using the masks. This includes, among others, patients with stents, valves, and flow disruption devices.

ResMed warned users to keep the mask magnets at least six inches away from medical devices or implants that may be affected.

According to the letter, ResMed has sold tens of millions of masks across the last nine years. 

ResMed is not the only company to run into problems with magnetic masks. Philips, which has battled large recalls across its respiratory medical devices, alerted customers to safety issues of its continuous PAP or bi-Level PAP therapy masks after reports similarly designed magnets were affecting implanted devices.

The US Food and Drug Administration (FDA) tagged Philips’ recall as Class I, the most serious classification. The recall involved over 18 million devices sold in the US.

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